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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218275

ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM)
667MG/VIAL
Marketing Status: Prescription
Active Ingredient: CEFTOBIPROLE MEDOCARIL SODIUM
Proprietary Name: ZEVTERA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 667MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218275
Product Number: 001
Approval Date: Apr 3, 2024
Applicant Holder Full Name: BASILEA PHARMACEUTICA INTERNATIONAL LTD ALLSCHWIL
Marketing Status:  Prescription
Patent and Exclusivity Information
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